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NCT01366196 · ClinicalTrials.gov registry record · NA
Pregabalin for the Treatment of Pain After Posterior Spinal Fusions
A NA study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- NA
- Development phase
- 86
- Enrollment target
NCT01366196 is a NA study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 86 participants.
The verdict
NCT01366196, a NA study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- NA
- Development phase
- 86 participants
- Enrollment target
Study Summary
Acute pain management is challenging in patients after spinal fusions, particularly since most have taken analgesics for prolonged periods before choosing the surgical alternative. Many of these patients are either preoperatively or become after surgery narcotic dependent. In addition, the narcotic based anesthetic required for the procedure, may induce a postoperative hyper-analgesia which may be partially responsible for the acute postoperative pain which is refractory to traditional doses of narcotics. Both the persistent nociceptive and neuropathic pain which these patients experience and narcotic-induced hyper-analgesia is mediated via non-conventional neural pathways. It is for these reasons, that in these patients postoperative pain is refractory to narcotic treatment. Postoperative pain in this situation is best managed using a multimodal approach. This technique allows the application of a number of treatment modalities which maximize pain reduction and minimize treatment side effects. Pregabalin (Lyrica) has been shown to be effective in the treatment of neuropathic pain. Pregabalin has a similar mechanism of action as gabapentin. Notably it has a rapid consistent absorption, linear pharmacokinetics, and a low potential for pharmacokinetic drug interactions. Hence, pregabalin should be a beneficial addition to the multi-modal pain regimen after spinal surgery; particularly in narcotic tolerant patients who respond poorly to conventional narcotic analgesics after surgery.
Interventions
- DRUG Placebo
- DRUG Pregabalin 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2008-10 |
| Est. Completion | 2012-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01366196
The ClinicalTrials.gov registry entry for NCT01366196 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01366196 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01366196 about?
NCT01366196 is a clinical study titled "Pregabalin for the Treatment of Pain After Posterior Spinal Fusions". Acute pain management is challenging in patients after spinal fusions, particularly since most have taken analgesics for prolonged periods before choosing the surgical alternative. Many of these patients are either preoperatively or become after surgery narcotic dependent. In addition, the narcotic ...
What is the current status of trial NCT01366196?
This trial is currently completed. It is a NA study. The enrollment target is 86 participants. The study started on 2008-10. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01366196?
The interventions under investigation include: Placebo (DRUG), Pregabalin 150 mg (DRUG).
Who is sponsoring clinical trial NCT01366196?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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